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Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancer

ConditionHormone-refractory Prostate Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorAstellas Pharma Global Development, Inc.

About this trial

The study will be conducted in 4 parts and will commence with dose escalation of VIR-5500 as a monotherapy (Part 1), followed by combination escalation (Part 3a), monotherapy dose expansion (Part 2) and combination dose expansion (Part 4a).

* Part 1 (Monotherapy Dose Escalation): Single-agent VIR-5500 dose escalation * Part 2 (Monotherapy Dose Expansion): Single-agent VIR-5500 dose expansion * Part 3 (Combination Dose Escalation): VIR-5500 plus another therapeutic agent dose escalation Part 3a (Combination Dose Escalation): VIR-5500 in combination with an androgen receptor signaling inhibitor (ARSI) * Part 4 (Combination Dose Expansion): VIR-5500 plus another therapeutic agent dose expansion Part 4a (Combination Dose Expansion): VIR-5500 in combination with an androgen receptor signaling inhibitor (ARSI)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have metastatic disease, defined by ≥ 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scan imaging

Have documented progressive mCRPC based on ≥ 1 of the criteria (per PCWG3)

PSA level ≥ 1 ng/mL that has increased on ≥ 2 successive occasions ≥ 1 week apart

Nodal or visceral progression as defined by RECIST v1.1 with PCWG3 modifications

Disqualifiers

Presence of dominant histopathological features representative of sarcomatoid, spindle cell, or neuroendocrine small cell components

Has acute or chronic infections

Has a concomitant medical or inflammatory condition that may increase the risk of toxicity to VIR-5500 (AMX-500), per the Investigator

Has lesions in proximity of vital organs

Trial design

Design model

Sequential

Treatments tested in this trial

  • VIR-5500

    Drug

    Pharmaceutical form: Solution for infusion Route of administration: Intravenous (IV) infusion

  • Androgen receptor signaling inhibitor (ARSI)

    Drug

    Oral administration

Treatment groups

437 Participants
are divided into 4 treatment groups
Group A: Part 1: VIR-5500 Monotherapy Dose EscalationExperimental treatment 1 intervention
Group B: Part 2: VIR-5500 Monotherapy Dose ExpansionExperimental treatment 1 intervention
Group C: Part 3a: VIR-5500 in combination with an ARSI for Dose EscalationExperimental treatment 2 interventions
Group D: Part 4a: VIR-5500 in combination with an ARSI for Dose ExpansionExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

All parts: Incidence of treatment emergent anti-drug antibodies (ADAs) to VIR-5500

Incidence and severity of AEs according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)

Time frame
from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months
2

Part 1 and 3a: Incidence of Dose Limiting Toxicities (DLTs)

Incidence and nature of DLTs according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)

Time frame
from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to Day 21 or Day 28
3

Part 2 and 4a: Prostate-Specific Antigen (PSA) response rate

Time frame
from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months
4

Part 2 and 4a: Objective Response Rate (ORR)

Time frame
from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months

Secondary outcomes

1

Part 2 and 4a: Number of participants with Adverse Events (AEs)

Time frame
from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months
2

Part 1 and 3a: PSA response rate

Time frame
from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months
3

Part 1 and 3a: Objective Response Rate (ORR)

Time frame
from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months
4

All parts: Duration of response (DoR)

Time frame
from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Astellas Pharma Global Development, Inc.

Lead sponsor

Vir Biotechnology, Inc.

Collaborator

Source ClinicalTrials.gov
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